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Completed

NCT Number: NCT05571800

Effect of Mango Consumption on Individuals with Pre-diabetes

This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

According to the Centers for Disease Control and Prevention (2016), at least 100 million adults in the United States are diagnosed as pre-diabetic or Type 2 diabetic. With the number of cases steadily increasing in this population, healthcare costs have subsequently increased for both the patient and the health care system. To date, there are few studies (limited to animal model and obese Type 2 diabetic humans) that have examined the efficacy of mangoes on health outcomes, particularly related to diabetes. Therefore, the purpose of the current study is to examine the effect of fresh mango on glycemic indices, body composition, and vascular health measures. Upon favorable outcomes, and with more definite evidence from human studies, mangoes can potentially be implemented in America's diet to help mitigate the advancement and diagnoses of pre and Type 2 diabetes and, as a result, aid in a reduction of healthcare costs. The current study is a 24- week, randomized, controlled experiment including 40 overweight or obese, pre-diabetic men and post-menopausal women aged 50 to 70 years with no diagnosed cardiovascular, metabolic, kidney, or other types of chronic disease to be included. Participants will be randomly assigned to one of two groups: 1) one fresh Tommy Atkins mango (120 g) per day or 2) an isocaloric granola bar per day for 24 weeks. Visits will include anthropometric measurements, glucose, and A1C values via finger prick, venous blood samples to analyze biomarkers related to glycemic control and lipid profiles, vascular measures, and body composition. To analyze the effects of the treatment, ANOVA and Bonferroni's test will be utilized. The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Free of any chronic diseases such as cancer
  • BMI of 18.5 kg/m2 to 34.9 kg/m2
  • wHbA1c values are 100 mg/dl to 125 mg/dl and HbA1C of 5.7-6.4 %

Exclusion criteria

  • Individuals diagnosed with cardiovascular diseases (CVD), type 2-diabetes, type 1 diabetes mellitus, other active chronic diseases such as cancer, asthma, glaucoma, kidney, liver and pancreatic disease
  • Uncontrolled hypertension (≥160/100 mmHg)
  • BMI <18.5 kg/m2 or >34.9 kg/m2
  • Not post-menopausal or have been taking hormone replacement therapy for less than 3 months
  • taking more than one anti-hypertensive or have been taking them for less than 3 months
  • Participating in a weight loss program or having lost or gain ≥10% bodyweight within the last 6 months
  • Smoke more than 1 pack/day
  • Consumption of >12 alcoholic drinks/week
  • Frequent mango consumers (>5 servings/2weeks)
  • In concurrent participation with another investigational study
  • Currently consuming any performance supplement (i.e. creatine, nitric oxide, whey/casein protein, branched chain amino acids).
  • None of the following special populations will be included: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, or prisoners.

Treatment and study plan

Mango

Other

120g of fresh Mango

Placebo

Other

200g isocaloric Granola Bar

Primary outcomes

  1. Effect of mango consumption on glycemic control using blood glucose measures

    Time frame: 3 years

    Blood glucose measures evaluated with finger prick and blood glucose meter

  2. Effect of mango consumption on glycemic control using HbA1c

    Time frame: 3 years

    HbA1c evaluated by finger prick and DCA analyzer

  3. Effect of mango consumption on glycemic control evaluated by Insulin

    Time frame: 3 years

    Insulin evaluated by blood draw Enzyme-linked immunosorbent assay

  4. Effect of mango consumption on glycemic control evaluated by HOMA-IR

    Time frame: 3 years

    HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay

  5. Effect of mango consumption on glycemic control evaluated by HOMA-β

    Time frame: 3 years

    HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay

Secondary outcomes

  1. Effect of mango consumption on indicators of cardiovascular health evaluated by systolic and diastolic blood pressure

    Time frame: 3 years

    Systolic and diastolic blood pressure evaluated by automated blood pressure monitor

  2. Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with FMD

    Time frame: 3 years

    Flow-mediated dilation (FMD) evaluated with high-resolution doppler ultrasound (HD11XE, Phillips Ultrasound, Bothwell, WA, USA) with a 3-12 MHz linear array transducer

  3. Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with PWV

    Time frame: 3 years

    Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index

  4. Effect of mango consumption on indicators of cardiovascular health evaluated by Indirect bioassay of in vivo endothelial function with ET-1

    Time frame: 3 years

    Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay

  5. Effect of mango consumption on indicators of cardiovascular health evaluated by biomarker of inflammation (C-reactive protein)

    Time frame: 3 years

    biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay

  6. Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile

    Time frame: 3 years

    lipid profile evaluated by blood draw and enzyme-linked immunosorbent assay consisting of

    • Triglycerides (TG)
    • Total cholesterol (TC)
    • Low-density lipoprotein cholesterol (LDL-C)
    • Oxidized LDL (Ox-LDL)
    • High-density lipoprotein cholesterol (HDL-C)
  7. Atherogenic risk ratio (TC/HDL-C, LDLC/HDL-C, HDL-C/LDL-C)

    Time frame: 3 years

    Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile

  8. Effect of mango consumption on body composition evaluated by lean mass

    Time frame: 3 years

    Lean mass evaluated by bioimpedance spectroscopy (BIS)

  9. Effect of mango consumption on body composition evaluated by fat mass

    Time frame: 3 years

    fat mass evaluated by bioimpedance spectroscopy (BIS)

  10. Effect of mango consumption on body composition evaluated by phase angle (PA)

    Time frame: 3 years

    Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/π

  11. Effect of mango consumption on body composition evaluated by weight

    Time frame: 3 years

    Weight evaluated by Ohaus Portable Electronic CS Series Scales

  12. Effect of mango consumption on anthropometric measure of Waist circumference (WC)

    Time frame: 3 years

    evaluated by Gulick fiberglass measuring tape with a tension handle

  13. Effect of mango consumption on anthropometric measure of HC

    Time frame: 3 years

    hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle

  14. Effect of mango consumption on anthropometric measure WC/HC ratio

    Time frame: 3 years

    waist to hip ratio (WC/HC)

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Mango Board

Registry information

Official study title

The Effects of Fresh Mango Consumption in Indices of Glycemic Control, Cardiovascular Health, and Body Composition in Normal Weight, Overweight and Obese Individuals with Prediabetes

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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